BrainStorm gets FDA okay for stem cell trial in MS patients

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TEL AVIV (Reuters) - BrainStorm Cell Therapeutics Inc has received approval from the U.S. Food and Drug Administration to begin a clinical trial of its experimental stem cell treatment in patients with progressive multiple sclerosis.

BrainStorm said on Monday it expects to start the U.S. Phase 2 trial in the first quarter of 2019.

The U.S.-Israeli company is already studying its treatment called NurOwn in patients with the neurodegenerative disease amyotrophic lateral sclerosis (ALS) and expects to have advanced Phase 3 trial results at the end of 2019 or early 2020.

There are as yet no FDA-approved autologous cellular therapies addressing MS or other neurological diseases, the company said.

MS affects about 1 million people in the United States and 2.5 million worldwide. About half will eventually develop the progressive disease, which may lead to increasing levels of motor, visual and cognitive functional impairment.

The global MS drugs market is expected to exceed $27 billion by 2025 from $16 billion in 2016, according to Research and Markets.